Actively Recruiting
Evaluation Contact X-ray Brachytherapy for Rectal Preservation in Intermediate Substage Rectal Adenocarcinoma
Led by Gustave Roussy, Cancer Campus, Grand Paris · Updated on 2025-12-04
212
Participants Needed
11
Research Sites
324 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Indication : Adult patients with intermediate low or mid rectal adenocarcinoma to be treated with total neoadjuvant therapy (TNT) potentially eligible for rectal preservation. Primary objective is to assess efficacy of contact X-ray brachytherapy (CXB) in addition to TNT in order to increase survival with organ preservation (OP), in selected intermediate risk group of rectal adenocarcinomas (size from 3.1 to 6 cm, cT2N1 or T3N0-1, M0).
CONDITIONS
Official Title
Evaluation Contact X-ray Brachytherapy for Rectal Preservation in Intermediate Substage Rectal Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed rectal adenocarcinoma
- Tumor size between 3.1 cm and 6 cm, less than 66% circumference, cT2N1 or T3N0-1, M0
- Tumor accessible by digital rectal exam in distal or middle rectum (less than 11 cm from anal verge), without significant anal canal involvement
- Operable patient
- About to start or currently receiving modified FOLFIRINOX chemotherapy
- Age 18 years or older
- WHO performance status 0 or 1
- Laboratory values within specified limits for bilirubin, liver enzymes, creatinine, neutrophils, platelets, hemoglobin, and albumin
- Negative pregnancy test for women of childbearing potential before first treatment
- Agreement to use effective contraception for sexually active women and men during and after study
- Ability and willingness to provide informed consent and comply with study procedures
- Affiliated with social security system or equivalent
You will not qualify if you...
- Other cancers within the past 5 years except in situ cervical cancer or basal cell skin carcinoma
- History of pelvic radiation or pelvic surgery
- Tumor stage T1-2N0 with size less than 3.1 cm or advanced tumor stages beyond specified criteria
- Stopped modified FOLFIRINOX after 3 or fewer cycles
- Dihydropyrimidine dehydrogenase (DPD) deficiency
- Electrolyte imbalances or prolonged QT interval on ECG
- Severe or uncontrolled cardiovascular disease
- Serious uncontrolled illness or infection
- Current pregnancy or breastfeeding
- Psychiatric illness impairing study understanding
- Under legal guardianship or unable to consent
- Inability to comply with medical follow-up due to social or psychological reasons
- Prior anti-tumor treatments for rectal adenocarcinoma
- Use of certain medications contraindicated with study drugs
- Known allergies to study drugs or their components
- Chronic inflammatory bowel disease or bowel obstruction
- Peripheral sensory neuropathy with functional impairment before treatment start
- Recent or concomitant use of specific interacting medications including live vaccines before chemotherapy start
- Combination use of warfarin with study chemotherapy not recommended or requiring special monitoring
- Use of pimozide or cisapride contraindicated due to heart rhythm risks before chemotherapy start
- Pregnant or breastfeeding women not eligible
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
Institut Sainte Catherine
Avignon, France, France, 84918
Actively Recruiting
2
Centre Léon Bérard
Lyon, France, France, 69008
Actively Recruiting
3
Centre de radiotéhrapie Charcot
Lyon, France, France, 69110
Actively Recruiting
4
Hôpital Européen
Marseille, France, France, 13003
Actively Recruiting
5
Centre d'oncologie et de radiothérapie
Mâcon, France, France, 7100
Actively Recruiting
6
Centre de Haute Energie
Nice, France, France, 06000
Actively Recruiting
7
Centre Antoine Lacassagne
Nice, France, France, 06189
Actively Recruiting
8
CHU de Saint Etienne
Saint-Etienne, France, France, 42270
Actively Recruiting
9
Institut de cancérologie de l'Ouest
Saint-Herblain, France, France, 44800
Actively Recruiting
10
Institut Gustave Roussy
Villejuif, France, France, 94805
Actively Recruiting
11
Orlam-Bayard
Villeurbanne, France, France, 69100
Actively Recruiting
Research Team
J
Jérome Durand Labrunie, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here